Draft UK Regulations on Product Conformity

When the UK leaves the EU (European Union), laws and regulations that refer to European institutions will no longer apply or work properly.

To prepare for this, the UK and Scottish governments are preparing laws which allow for the UK's new position outside the EU.

In the event of a ‘no deal’ Brexit these new laws will take immediate effect. If there is a deal then the changes are likely to be postponed until the end of a transition period of months or years, but some changes will still be required before the end of any transition period.

The draft amendments to the current UK regulations on conformity assessment were recently published. Among other things, they provide for unilateral recognition of EU requirements and the CE marking, so that products that meet these requirements can continue to circulate in the UK after Brexit. It is intended that the UKCA Mark will replace the CE Mark in future, but no date has been set for when this will happen.

The new statutory instrument amends 29 pieces of UK legislation relating to single market requirements for specific groups of products. They set out product safety and conformity assessment requirements for specific products including industrial machinery, electrical equipment, pressure equipment, products for hazardous atmospheres and equipment for use on off-shore platforms.

The key provisions of the draft amendments to the statutory instruments related to product safety are detailed below: -

  • Omit “CE Mark” and substitute “UKCA Mark”
  • Omit the definition of “Official Journal”; the Secretary of State will authorise designated standards
  • Omit the definition of “harmonised standard” substitute “designated standard”
  • Omit the definition of “EU declaration of conformity”; substitute “declaration of conformity”;
  • Omit the definition of “Union harmonisation legislation” substitute “statutory requirements”
  • Omit “EU-type” in each place where it occurs; substitute “Type"
  • Manufacturer’s authorised representatives must be established in the United Kingdom
  • "Importer" means a person who is established in the United Kingdom and places equipment from a country outside of the United Kingdom on the market
  • Instructions and safety information must be clear, legible and in easily understandable English
  • "Designated standard" means a technical specification which is adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory;
  • Omit competent national authorities of any other Member State
  • The Secretary of State must:
    • Assign an approved body identification number to each approved body;
    • List the activities for which they have been approved; and
    • List any restrictions on those activities.

Product Conformity Requirements on leaving the Single Market

There is still uncertainty about if and when the UK will leave the single market. There will be little effect on manufacturers until it actually happens. There’s a possibility of a “No-deal Brexit” and of the UK leaving the single market on October 31st but the most likely outcome is still that the UK will remain in the single market for a year or two under a withdrawal agreement (or possibly even indefinitely in a Norway style customs arrangement).

However if/when the UK does leave the single market; it becomes a “third country.” The main result for UK manufacturers exporting products to the EU27 will be that the person receiving them in the EU27, i.e. the distributor or end user, must fulfil the obligations of an EU “importer” including:

  • Mark the product with their name and address
  • Understand and check the markings, declarations and technical file
  • Satisfy themselves that the CE marking is complete
  • Be the primary point of contact for the EU authorities
  • Be prepared to cooperate with the authorities if there is a product recall or similar.

Products for the EU27 will continue to be CE marked. UKCA marking will not be formally recognised there.

After an as-yet unspecified transitional period, the conformity declaration requirements for products supplied in the UK will change:

  • The “UK Conformity Assessed” UKCA logo will replace the CE mark.
  • The UK "declaration of conformity" will replace the "EU declaration of conformity”
  • For self-certified products, there will be an unspecified transition period during which there will be a choice between CE marking and UKCA marking for UK products.
  • For products which currently require approval by a Notified Body, UKCA will be mandatory from exit day and a UK conformity assessment body must certify the product.

It seems very likely that if there is a deal at all then it will only emerge at the very last minute and in the meanwhile there will be much confusion and little certainty about what will happen and when. However, there are things which manufacturers and others can be doing in preparation for Brexit so please contact us for specific advice if you need it.

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